FDA.reportPublic FDA data

TABRECTA

Product NDC
0078-0709
11-digit product format
000780709
Labeler code
0078
Product ID
0078-0709_0df064bb-358d-4c21-8525-9b8b9a5845a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
capmatinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA213591
Marketing category
NDA
Marketing start
2020-05-06
Substance
CAPMATINIB HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Kinase Inhibitor [EPC], Mesenchymal Epithelial Transition Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TABRECTA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPMATINIB HYDROCHLORIDE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC2A374O70X
Rxcui2362234, 2362240, 2362242, 2362244

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d0e53982-523a-427a-812d-02a7a146a4a9Product name120200511
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0709-56TABRECTA56 in 1 BOTTLETABLET, FILM COATED5617
0078-0709-94TABRECTA56 in 1 BOTTLETABLET, FILM COATED5617

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0709-56EA - Each0078-07098cd8f8c1-2b76-4674-88f7-d33d180bae8b12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0709TABRECTA (CAPMATINIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]15Current NDC, Legacy NDC, 2 package rows20250403_455892c3-d144-4ba8-9ab4-79cabff9876d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2362234capmatinib 150 MG Oral TabletPSN455892c3-d144-4ba8-9ab4-79cabff9876d17
2362242capmatinib 200 MG Oral TabletPSN455892c3-d144-4ba8-9ab4-79cabff9876d17
2362240TABRECTA 150 MG Oral TabletPSN455892c3-d144-4ba8-9ab4-79cabff9876d17
2362244TABRECTA 200 MG Oral TabletPSN455892c3-d144-4ba8-9ab4-79cabff9876d17
2362240capmatinib 150 MG Oral Tablet [Tabrecta]SBD455892c3-d144-4ba8-9ab4-79cabff9876d17
2362244capmatinib 200 MG Oral Tablet [Tabrecta]SBD455892c3-d144-4ba8-9ab4-79cabff9876d17
2362234capmatinib 150 MG Oral TabletSCD455892c3-d144-4ba8-9ab4-79cabff9876d17
2362242capmatinib 200 MG Oral TabletSCD455892c3-d144-4ba8-9ab4-79cabff9876d17
2362234capmatinib 150 MG (capmatinib HCl 176.55 MG) Oral TabletSY455892c3-d144-4ba8-9ab4-79cabff9876d17
2362242capmatinib 200 MG (capmatinib HCl 235.4 MG) Oral TabletSY455892c3-d144-4ba8-9ab4-79cabff9876d17
2362240Tabrecta 150 MG (as capmatinib HCl 176.55 MG) Oral TabletSY455892c3-d144-4ba8-9ab4-79cabff9876d17
2362240Tabrecta 150 MG Oral TabletSY455892c3-d144-4ba8-9ab4-79cabff9876d17
2362244Tabrecta 200 MG (as capmatinib HCl 235.4 MG) Oral TabletSY455892c3-d144-4ba8-9ab4-79cabff9876d17
2362244Tabrecta 200 MG Oral TabletSY455892c3-d144-4ba8-9ab4-79cabff9876d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0709-560007807095656 TABLET, FILM COATED in 1 BOTTLE (0078-0709-56) 2020-05-060000-00-00NoNoCurrent
0078-0709-940007807099456 TABLET, FILM COATED in 1 BOTTLE (0078-0709-94) 2020-05-060000-00-00YesNoCurrent